- In a population with type 1 diabetes representative of clinical practice in the United Kingdom, a change in basal insulin to insulin glargine 300 units/mL (U300) was associated with statistically significant and clinically meaningful reduction in HbA1c, without significant changes in basal insulin dose and weight.
Why this matters
- The use of U300 in people with type 1 diabetes mellitus is supported by results from 2 phase 3, randomised, controlled trials; however, no participants from the United Kingdom were included in these trials, and no real-world evidence exists regarding the use of U300 in type 1 diabetes in the UK clinical practice.
- This retrospective, observational, single-arm study included patients with type 1 diabetes (n=298; mean age, 42.1 years; mean HbA1c, 79 mmol/mol [9.4%]) who were prescribed their first dose of U300 ≥6 months before data collection (August 2015) and had HbA1c results within 3 months before starting U300.
- Primary outcome included change in HbA1c from baseline to month 6 after U300 initiation.
- Funding: Sanofi UK.
- HbA1c significantly reduced from baseline [78 mmol/mol (9.3%)] to month 6 post initiation of U300 [74 mmol/mol (8.9%)], with a mean difference of −4 mmol/mol (–0.4%; P<.001 n="188).</li">
- Significant increase in basal insulin dose of 1.3 units from U300 initiation to 6 months was observed (P<.001 n="275).</li">
- No clinically significant difference in weight between baseline and month 6 was reported (mean difference, +0.7 kg; P=.084; n=115).
- Documented severe hypoglycaemic episodes were experienced by 6/298 and 4/298 participants during the 6 months before and after U300 initiation, respectively.
- Ketoacidosis episodes requiring Accident and Emergency department visits or hospitalisation were documented in 4/298 and 6/298 participants, before and after U300 initiation, respectively.
- Observational design.